Methods to Evaluate the Preclinical Safety and Immunogenicity of Genetically Modified Live-Attenuated Leishmania Parasite Vaccines

Methods Mol Biol. 2016:1403:623-38. doi: 10.1007/978-1-4939-3387-7_35.

Abstract

Live-attenuated parasite vaccines are being explored as potential vaccine candidates since other approaches of vaccination have not produced an effective vaccine so far. In order for live-attenuated parasite vaccines to be tested in preclinical studies and possibly in clinical studies, the safety and immunogenicity of these organisms must be rigorously evaluated. Here we describe methods to test persistence in the immunized host and immunogenicity, and to identify biomarkers of vaccine safety and efficacy with particular reference to genetically attenuated Leishmania parasites.

Keywords: Biomarkers; Immune suppression; Immunogenicity; Innate immunity; Non-pathogenicity; Persistence; Protective antigens; Safety.

MeSH terms

  • Animals
  • Biomarkers / metabolism
  • Cell Membrane / parasitology
  • Drug Evaluation, Preclinical / methods*
  • Female
  • Genetic Engineering*
  • Immunity, Innate
  • Leishmania / immunology*
  • Macrophages / cytology
  • Mice
  • Protozoan Vaccines / adverse effects*
  • Protozoan Vaccines / genetics
  • Protozoan Vaccines / immunology*
  • Safety*
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / genetics
  • Vaccines, Attenuated / immunology

Substances

  • Biomarkers
  • Protozoan Vaccines
  • Vaccines, Attenuated